PINNACLE 100 ACET CUP 54MM 1217-01-054 121701054

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-30 for PINNACLE 100 ACET CUP 54MM 1217-01-054 121701054 manufactured by Depuy Orthopaedics Inc Us.

Event Text Entries

[186759403] (b)(4). Initial reporter occupation: lawyer. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[186759404] Litigation alleges that the patient suffers from damage to his hip joint and body and also alleges elevated metal ions. After review of medical records patient was revised to address failed left total hip arthroplasty. There was also pain, discomfort, joint instability, walking difficulty, synovitis and foreign body reaction. Revision notes reported that the left metal on metal total hip arthroplasty and developed symptoms of discomfort and instability. Radiographs revealed a vertical acetabular cup and labs revealed elevated metal ions. This was ultimately excised almost entirely along with adjacent reactive synovitis. Revision notes stated that there was a gray nodule protruding through a defect in the iliotibial band. The femoral head component was removed and minimal fretting corrosion at the trunnion of the femoral neck was observed. Removed head, liner and cup. During revision a pseudotumor containing metal debris was removed. Patient experienced pain with activities and metallosis. Doi: (b)(6) 2006; dor: (b)(6) 2012 (left hip).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1818910-2020-09618
MDR Report Key9900331
Report SourceCONSUMER,OTHER
Date Received2020-03-30
Date of Report2012-07-12
Date of Event2012-08-15
Date Mfgr Received2020-03-16
Device Manufacturer Date2006-03-17
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465820988
Manufacturer CountryUS
Manufacturer Postal Code465820988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePINNACLE 100 ACET CUP 54MM
Generic NamePINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Product CodeLPH
Date Received2020-03-30
Model Number1217-01-054
Catalog Number121701054
Lot NumberAJ5GN1000
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-30

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